Heat Retention Head Wrap Use for Re-warming of Infants Requiring Cardio-Pulmonary Bypass

Completed · Phase 1

Conditions studied: Impaired Thermoregulation

In brief

This is a phase I descriptive pilot study to determine the feasibility of using the Heat Retention Head Wrap on infants during the re-warming period following cardio-pulmonary bypass.

Key facts

Study ID

NCT01675830

Run by

Cardiology Clinical Research & Regulatory Group

People needed

10

Starts

2011-11-01

Expected to finish

2012-03-01

Last updated by the study team

2015-03-31

Who can join

Age: 0 and older, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Undergoing CPB surgery.
• Weigh ≥ 3 and ≤ 10 kg.
• Cooled to 24-30 degrees Celsius.
• Head circumferences between 33-48 cm.
• Scalp free of skin lesions such as reddened areas, ulcerations, abrasions, burns, and hemangiomas.

You may not qualify if…

• Require cooling below 24 degrees Celsius at any point during CPB surgery.
• Weigh less than 3 kg or more than that 10kg.
• Are premature or < 37 weeks corrected gestational age.
• Have a head circumference smaller than 33 cm or larger than 48 cm.
• Have a known or previously diagnosed neurological trauma, malignant hyperthermia, stroke, seizure, VP shunt, evidence of scalp lesions, or other known comorbidity.
• Have hair braided close to the scalp.
• Infants with known allergy or sensitivity to polyethylene terephthalate (known as Mylar)

Where it is running

• Boston Children's Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.